Amixon mixers and infant formula manufacturing - Mixing the next generation of infant nutrition
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− amixon® whitepaper − Mixing the next generation of infant nutrition amixon® mixers and infant formula manufacturing The key role of mixing equipment in producing safe and healthy powdered infant formula
INTRODUCTION Ensuring the highest standards for the next generation It is the most natural thing in the world for parents to want the very best for their children. But ideas about what is actually best for children differ throughout history as science, cultural attitudes, and society have evolved. Over the past few decades, the field of infant and pediatric nutrition has benefited tremen- dously from enhanced scientific knowledge and innovative technology. But while we now know more than ever about what babies need to grow up strong and healthy, there remain significant challenges in both manufacturing infant formulas that can fulfill these needs and marketing baby nutrition products in a way that is discerning to the diverse needs of new parents. Entrusted to nourish the most vulnerable among us, baby nutrition products must be developed and manufactured with the utmost care and transparency. High-performance, hygienic mixing equipment plays a key role in ensuring that these products live up to the science behind their development. This whitepaper from amixon GmbH examines some of the dominant forces currently shaping the market for infant formula and baby foods and explores their impact on the manufacturing process. Our evolving scientific understanding of the composition of breast milk is opening new possibilities for infant nutrition products to better nourish babies. But without sophisticated processing technology, scientific knowledge can only go so far in improving products. Industrial mixing technology is key in developing and manufacturing infant formulas and baby foods that can live up to health claims and guarantee safety. 2
ABOUT AMIXON
Industrial mixing technology
made in Germany
For nearly 40 years, amixon® has been a market leader in the manufacture of sophisti-
cated, high-precision mixing equipment for diverse processing needs. Made in Germany
from food grade materials, outfitted with hygienically optimized proprietary technology,
and customized to the exact specifications of your products, amixon® mixers offer state-
of-the-art bulk material processing solutions for manufacturers of infant formula, baby
foods, nutraceuticals, and pharmaceuticals.
3
Content
1. A new generation of infant nutrition 6
1.1. The evolving science of baby nutrition 6
1.2. Conscientious parenting and the growing spectrum of 8
infant nutrition products
2. The evolving responsibility of infant formula manufacturers 9
2.1. Adding ingredients: the question of ratio 10
2.2. Ensuring purity and added ingredient effectiveness 10
3. The role of mixers in the production of safe and healthy infant formulas 11
3.1. Creating precise and nutritionally effective mixtures 11
3.2. Exceptional hygiene and construction 13
3.3 Continuous mixing on high-volume production lines 14
4. Conclusions 15
4
amixon® Vertical Twin-Shaft Mixer HM
Growing awareness of the
benefits of HMOs and probiotics
Allergen prevention and cow-
free products: the rise of niche
market segments
Synthesizing HMOs and proving
their efficacy
Preserving bioactive ingredients
in shelf-stable products
The crucial importance of
hygiene and traceability
The role of mixers in fulfilling
health and safety claims
5
1 A new generation of
infant nutrition
In grocery stores around the world, parents can choose between dozens of products
formulated to meet the nutritional needs of their infants and young children. As wide as
this selection already is, it is continuously growing. Formula and baby food manufactur-
ers are in constant collaboration with researchers to develop and test new formulas.
Driving the continued growth in the variety of baby nutrition products is scientific
advancement on the one hand, and changing attitudes about health and parenting on
the other. The past few decades have seen drastic changes in our understanding of
the composition of breast milk and its different components’ roles in infant growth and
development. Furthermore, consumers are more conscious of the health and environ-
mental consequences of their purchasing decisions than ever before. As such, manu-
facturers of infant formula and baby food have a responsibility to create products that
address both the latest science and generational attitudes about parenting.
1.1 The evolving science of baby nutrition
Since the mid-1990s, commercial infant formulas have been able to replicate breast milk
in terms of its ratio of proteins, fats, vitamins, and minerals (Callahan 2019). But modern
science has shown that breast milk has not only evolved to have a nutrient composition
specific to the rapid growth that babies experience during their first year of life, but that it
is also bioactive.
The last decade has produced numerous studies confirming that breast milk is filled
with hundreds of living microscopic components, each with a unique and as of yet
not completely understood role in infant development – from protecting babies from
pathogens to building their immune systems.
Though commercial infant formula may never achieve an exact replication of breast
milk at the molecular level, this growing scientific knowledge is helping to make infant
nutrition products better. Afterall, not all babies can be breastfed, and there is an ethical
imperative to ensure the availability of safe and efficient formulas that meet babies’
nutritional needs.
6
The scientific community’s growing understanding of the complexities of breast milk has encouraged continuous
research and development on the part of infant formula manufacturers. In particular, the past few years have seen
the addition of the following ingredients to infant formulas:
Human milk oligosaccharides
(HMO)
After lactose and fat, the third-most plentiful component in breast milk is a
group of over 150 different sugar molecules known as HMOs – none of which
are actually digestible by the infants themselves. Studies have shown HMOs to
play a number of beneficial roles in infant development. Primarily, this family of
sugar molecules act as a prebiotic food source for Bifidobacterium, a beneficial
microorganism found in the gut microbiomes of infants. HMOs have also been
shown to confer a number of other benefits including protecting infants from
pathogens (Triantis, et al. 2018), modulating cell growth (Ray, et al. 2019), and
reducing inflammation (Wickramasinghe, et al. 2015).
Milk fat globule membranes
(MFGM)
The mammary glands of breastfeeding mothers secrete fat droplets packaged
in an intricately structured three-layer membrane. The membrane of the globule
contains a plethora of proteins, cholesterol, and phospholipids that are thought to
aid in infant brain development and immune function (Lee, et al. 2019). MFGMs
have historically been absent from infant formulas, but researchers have in recent
years taken to adding a cow-derived version of the structure to their products.
Lactoferrin
Lactoferrin is a protein that combats pathogens and harmful bacteria and is
found in much higher quantities in human milk than in cow’s milk. Levels of
lactoferrin rise in a mother’s milk when her baby is ill, and its powerful antiviral
and immunomodulatory properties have even made this protein the subject
of research as a potential preventative and adjunct treatment for COVID-19
(Chang, et al. 2020).
7
1.2 Conscientious parenting and the growing spectrum of infant nutrition products
In recent decades, scientific progress and the wide availability of information have made the public more critical and
conscientious about the potential health implications of their consumption than ever before.
Especially when it comes to purchases that could impact the health of their babies, consumers are understandably
anxious and seek to be as informed as possible when making decisions. Millennials, who comprise 90% of today’s
new parents, are nearly twice as likely to express concern about what their children are eating than Gen X parents
were, and nearly three times more likely than Baby Boomer parents were (Steinmetz 2015).
To be certain, conflicting information abounds and expanding access to information does not necessarily equate with
a better-informed public. But growing awareness about health topics such as the gut microbiome and allergens, as
well as an increasingly environmentally-conscious generation of parents, are giving rise to new sorts of baby nutrition
products beyond traditional infant formula and baby foods. Here are some of the emerging infant nutrition products
fueled by changing attitudes about health and parenting:
Probiotic supplements
Scientists warn that the growing prevalence of antibiotic use, c-section delivery, and formula feed-
ing is leading to a “generational loss” of the critical gut bacteria B. infantis among infants in indus-
trialized nations (Watson 2017). Even for breastfed babies who were delivered vaginally, a growing
number of new mothers no longer have any B. infantis to pass on to their infants. This issue has led
some life science companies to develop special supplements containing activated B. infantis that
parents can mix with pumped breastmilk or formula. The development of products such as these
corresponds with rising public interest in probiotics generally. A 2019 analysis of product reviews
in 19 countries revealed a huge boom in consumer interest in probiotics, and that probiotic supple-
ments for children generated more customer engagement than any other category (Cutler 2019).
Allergen prevention products
In industrialized nations, childhood food allergies are on the rise. In the United States, for instance,
food allergies among children increased 50% from 1997 to 2011 (Jackson, et al. 2013). Both genet-
ics and environmental factors influence the development of childhood food allergies, but many re-
searchers point to the early integration of small amounts of common allergens into babies’ diets as
having the potential to prevent food allergies. As such, the past few years have seen a surge of new
allergen introduction products, ranging from powdered supplements to be mixed with baby foods to
toddler snack foods like puffs and crackers.
8
Plant-based baby nutrition
Historically, the vast majority of infant formula has been made with cow’s milk, with a few alter-
native options made from soy, goat or sheep’s milk. But growing awareness of animal welfare and
environmental issues as well as health concerns relating to lactose and soy intolerance have fueled
the growth of an emerging market segment for alternative baby nutrition products. 2020 saw the
launch of the first vegan and soy-free infant formula on the U.S. market as well as steady growth in
the global market for vegan baby food products. Other plant-based ingredients for infant formula,
such as DHA algae oil, are projected to see impressive annual market growth rates as high as 8.5%
in the coming years (Global Market Insights, Inc. 2020).
2 The evolving responsibility of
infant formula manufacturers
Science is expanding what we know about the composition of breast milk and its im-
portance to the health and development of growing babies, but translating these find-
ings into a safe and effective infant formula product is no easy task. Much remains
unknown about how different molecules interact at different ratios, and preserving
probiotic ingredients while simultaneously minimizing harmful bacterial risks proves
challenging.
When new insights into the composition of breast milk come to light, it is not enough
for infant formula manufacturers to simply synthesize these ingredients to the best
of their ability and add them to products. Manufacturers must also carry the burden
of proof in validating that these ingredients are safe, tolerable for the delicate infant
digestive system, and actually confer benefits to growing babies. Doing so necessi-
tates a robust research and development infrastructure for conducting product trials,
as well as a sophisticated production line capable of manufacturing such complex
products in the first place.
9
2.1 Adding ingredients: the question of ratio 2.2 Ensuring purity and added ingredient effectiveness
Though the presence of components such as HMO, Hygiene is a top priority for any food manufacturer, but
MFGM, and lactoferrin in breast milk have been shown nowhere is this focus more pronounced than in the field
to benefit infant development, it is not always clear how of infant and young child nutrition. Because a baby’s im-
safe or effective their replication in formula is. mune system will only develop over the course of the
first year of life, manufacturers of infant formula must
For instance, microbial engineering has made it possible take exceptional caution to ensure product purity and
to manufacture a handful of HMOs for addition to infant include clear and transparent labeling about how their
formula, with 2’-FL and LNnT being the most common products are to be safely stored and prepared.
(Zeuner, et al. 2019). But given that over 150 different
types of HMOs are present in breast milk, there remain The abundance of caution with which infant formula ma-
questions about which HMO types should be added to nufacturers must operate can however prove challenging
infant formula and in what concentration. in the development of products containing beneficial bio-
active ingredients. In their powdered form, infant formu-
After all, even in the gold standard of breast milk, cer- las are shelf-stable products. But they are not sterile, and
tain ratios of HMOs have been shown to be less than so miniscule amounts of naturally occurring pathogens
ideal for infant health. One study on nursing mothers may proliferate in packaged products with prolonged sto-
in India found that elevated levels of 2’-FL and LNnT in rage and caregiver handling (Cho, et al. 2019). Of particu-
breast milk correlate with greater incidence of rotavirus lar concern in infant formula are Cronobacter sakazakii,
and gastrointestinal infections in infants (Ramani, et Salmonella enterica, and Staphylococcus aureus, which
al. 2018). Other studies have shown that specific HMO together have caused hundreds of documented cases of
compositions in breast milk may cause infants to gain illness and dozens of infant deaths over the years.
weight excessively (Larsson, et al. 2019) or develop food
allergies (Miliku, et al. 2018). In order to destroy these bacteria and ensure safe con-
sumption, WHO advises that caregivers reconstitute
These studies point to the risk that too-high concent- powdered infant formula with water no cooler than 70° C.
rations of just one or two HMOs in infant formula may However, this high temperature will also kill any probiotic
have unintended negative effects. Though development bacteria, nullifying the benefits of these added and often
trials of infant formulas containing HMOs have shown expensive ingredients. Solving this dilemma requires
promising results, further research is needed in order the development of rigorous in-line detection processes
to design an HMO mixture that is optimally balanced. (Song, et al. 2018), an exceedingly hygienic manufac-
Furthermore, sophisticated processing equipment is turing operation, and sophisticated batch tracing capa-
necessary to ensure that these delicate ingredients are bilities, as well as innovative approaches to developing
homogenously incorporated into infant formula at precise products designed for safer handling by consumers.
and scientifically validated concentrations.
103 The role of mixers in the
production of safe and
healthy infant formulas
The high health and safety standards to which infant nutrition products are held can
only be fulfilled if raw material components are prepared in quality-controlled systems.
As the vessel in which diverse components come together, mixers are crucial to both
product quality and processing efficiency.
The final section of this whitepaper discusses three central ways in which high-per-
formance mixing equipment is critical to the cost-effective production of powdered
infant formula that is both safe and nutritionally optimal. As a decades-long partner to
businesses in the food, nutraceuticals, and pharmaceuticals industries, amixon® has
extensive knowledge and experience in engineering sophisticated powder mixers to
meet demanding health, safety, and performance standards.
3.1 Creating precise and nutritionally effective mixtures
As discussed in the previous chapters, replicating the complexities and enigmatic pro-
perties of breastmilk in powdered infant formula no easy task. This is true both from
the standpoint of research and product development and from the standpoint of manu-
facturing technology.
Once researchers have developed a beneficial recipe with a proven composition of deli-
cate, microscopic components, the recipe must then undergo technical implementation
on the production floor. Mixing is among the most critical and challenging processing
steps in ensuring that the resulting infant formula contains precise concentrations of
beneficial components and can fulfill health claims.
From minerals, to probiotic bacteria, to HMO molecules, many components in infant
formula are only present in very small concentrations. To make the mixing task even
more challenging, these components have especially delicate particle structures and
can lose their efficacy with exposure to heat, shear, or oxidation.
11The construction of the HM twin shaft mixer from amixon®.
The HM vertical twin-shaft mixer from amixon® offers a can effectively create this current, resulting in perfectly
particularly gentle yet effective solution for incorporating homogenous mixtures even when filled to just 10 to 15
such small and sensitive components into bulk ingre- percent its capacity.
dients. The mixing vessel consists of two cylinders that
have been fused together, each housing a helical mixing The mixing results of the HM mixer are so consistent
tool. Both mixing tools rotate in the same direction and that only a single sample analysis must be performed
are designed with a slight incline of 30°. The diameter of per batch in order to ensure that the powdered infant
the mixing tool is wide enough to convey nearly a quarter formula has a precise nutrient composition validated
of all the goods within the vessel in just a single rota- by the latest pediatric science.
tion. The peripheral speed of the mixing tool is typically
adjustable between 0.5 m/s to 3 m/s.
The helical mixing blades gather the powdery contents
at the periphery of the mixing vessel, conveying them
upwards. Once the powders have reached the top, they
then flow back down along the center of the mixing shaft.
A three-dimensional current is created in the space bet-
ween the upward flow at the periphery and the downward
flow in the center. The actual mixing, i.e. particles chan-
ging places with one another, happens between these two
macro flows.
This three-dimensional mixing flow ensures technically
ideal mixing results in as few as 20 to 90 rotations, thus
requiring only minimal energy input and shear. Even at
extremely low filling levels, the HM twin-shaft mixer
Flow principle HM
123.2 Exceptional hygiene and construction
Any facility that manufactures infant formula can only reliably prevent microbial contamination and allergen-free
processing by means of thorough wet-cleaning protocols. amixon® mixers are designed to simplify the wet-cleaning
process in a number of ways:
Hygienic design
amixon® mixing vessels and blades are made from food-grade stainless steel
with a smooth, sanitary finish to minimize the build-up of material residues. The
mixing shaft is driven and mounted only from the top, out of contact with the
mixing goods. The ergonomic doors provide easy access to the mixer interior
for simplified maintenance and inspection. Furthermore, the doors are produced
using the CleverCut® method, during which an O-ring is inserted into the groove,
creating a gastight, dust-free seal that is both close to the product and free of
deadspace.
Innovative technology for
complete discharging
amixon® mixers with conical floors can quickly discharge flowable bulk materi-
als without segregation. But ComDisc® technology makes it possible to achieve
up to 99.997% discharge even in flat-bottomed mixers. Installed at the bottom
of the mixing shaft, this flexible mechanism floats through the product during
the mixing process and lowers to the vessel floor upon discharging. There, it
sweeps the bottom of the mixer in a radial fashion, pushing the mixing goods
towards the discharge outlet. The result is less product loss and a cleaner mix-
er interior.
Automated WaterDragon® wet-
cleaning and drying mechanism
A series of retractable washer nozzles are installed at strategic points within the
mixing vessel. After discharging, the nozzles automatically protract from be-
hind their air-tight closure flap. Driven by the pressure from the wash water, the
washing heads rotate to spray down the interior of the mixing vessel. The system
is designed to automatically drain itself of residual rinse water before funneling
warm air into the vessel via the nozzles to completely dry the mixer interior.
133.3 Continuous mixing on high-volume production lines
A modern powder filling and packaging machine can process a flow volume of roughly 20 m2 (roughly 10 tons) per
hour. In order to work at this pace, infant formula manufacturing facilities must have a logistic concept capable of
coordinating the various processing stages and equipment involved.
In our experience, there are two primary ways to approach mixing on a high-volume infant formula production line. In
one scenario, a precision mixer (such as the amixon® HM twin-shaft mixer) with a batch volume of 10 m2 or more is
implemented such that it feeds into multiple filling machines. In another scenario, multiple smaller mixers with batch
volumes ranging from 1 to 2 m2 are implemented with each mixer feeding into its own dedicated filling machine.
This second concept is known as an end-of-
line operation and involves a vertical arrange-
ment of processing equipment in which the
materials flow gravimetrically and continu-
ously to the next processing stage.
There are several benefits to end-of-line mix-
ing. For one thing, by eliminating batch chan-
geovers and intermediate cleanings, continu-
ous processes can operate at higher produc-
tion speeds than batch processes. Another
benefit of end-of-line mixing especially ger-
mane to infant formula production is the fact
that each category of product gets its own
dedicated production line. As such, end-of-
line operations are ideal for products where
cross-contamination may be an issue – such
as soy-free or dairy-free infant formula for
babies with food allergies.
An example of an end-of-line mixing operation featuring a spray tower at the top level,
KoneSlid® precision mixers in the center, and packaging machines at the bottom.
14But a downside of conventional end-of-line mixing is a certain amount of product loss at the beginning of each cam-
paign. Typically, when a continuous mixer is started up, the first of its contents to be discharged do not conform to
the overall recipe. This is because the flow rates of each individual feeding mechanism still need to be calibrated.
amixon® offers an innovative solution to this challenge. The KoneSlid® precision mixer was specially developed
for processes with a high degree of variables. Even at low rotational speeds, KoneSlid® mixes gently and precisely,
achieving ideal homogeneity in as few as 20 to 30 revolutions, and often eliminating the need for preparing premixes.
The unique mixing flow generated within the vessel makes it possible to completely account for the calibration phase
within the mixture. Furthermore, the inverted cone floor of the KoneSlid® mixer ensures rapid and complete discharge
without segregation or material piling – another feature that helps to ensure the infant formula composition remains
consistently homogenous.
The innovative design of the KoneSlid® mixer floor enables flowable goods to be
discharged in a matter of seconds without segregation.
4 Conclusions
Infant formula: a product at the intersection of nutritional science, technology, and
parenting
For the health of the next generation, manufacturers of infant formula have a respon-
sibility to make the best product they can according to the latest nutritional science,
technological capabilities, and the changing needs of parents. As cultural attitudes
shift and research advances our knowledge, formula companies must be able to rely
on effective processing equipment that can empower them to develop products that
are as beneficial as possible to infant health.
In the production of powdered infant formula, high-performance mixing equipment
is crucial for the manufacture of safe baby nutrition products that can live up to the
science behind their development. Our unparalleled expertise in powder processing
has made amixon® a partner to many global market leaders in infant nutrition.
Each infant nutrition manufacturing facility has its own unique production line. As such,
every piece of industrial mixing equipment must be engineered for the customer’s spe-
cific needs. To arrange a meeting with an amixon® powder processing expert to discuss
your specific mixing requirements, simply e-mail us at: sales@amixon.com
15WORKS CITED Callahan, Alice. 2019. “In Pursuit of Better Baby Formula.” Smithsonian. https://www.smithsonianmag.com/innovation/pursuit-better-baby-formula-180973388/. Chang, Raymond, et al. 2020. “Lactoferrin as potential preventative and adjunct treatment for COVID-19.” Internatio- nal Journal of Antimicrobial Agents. https://www.sciencedirect.com/science/article/pii/S0924857920303010. Cho, Tae Jin, et al. 2019. “Underestimated Risks of Infantile Infectious Disease from the Caregiver’s Typical Handling Practices of Infant Formula.” Scientific Reports. https://www.nature.com/articles/s41598-019-46181-0. Cutler, Nikki. 2019. “Product reviews reveal ‚clear gap‘ in the probiotics market.” Nutra Ingredients. https://www.nutraingredients.com/Article/2019/02/22/Product-reviews-reveal-clear-gap-in-the-probiotics-market. Global Market Insights, Inc. 2020. “DHA Algae Oil for Infant Formula Market Projected to Exceed $435 Million by 2026.” GlobeNewswire. https://www.globenewswire.com/news-release/2020/10/05/2103294/0/en/DHA-Algae-Oil-for-In- fant-Formula-Market-projected-to-exceed-435-million-by-2026-Says-Global-Market-Insights-Inc.html. Jackson, KD, et al. 2013. Trends in allergic conditions among children: United States, 1997-2011. Data brief, Hyatts- ville, MD: National Center for Health Statistics. http://www.cdc.gov/nchs/products/databriefs/db121.htm. Larsson, Melanie W., et al. 2019. “Human Milk Oligosaccharide Composition Is Associated With Excessive Weight Gain During Exclusive Breastfeeding—An Explorative Study.” Frontiers in Pediatrics. https://doi.org/10.3389/fped.2019.00297. Lee, Hanna, et al. 2019. “Compositional Dynamics of the Milk Fat Globule and Its Role in Infant Development.” Fron- tiers in Pediatrics. https://www.frontiersin.org/articles/10.3389/fped.2018.00313/full. Miliku, K, et al. 2018. “Human milk oligosaccharide profiles and food sensitization among infants in the CHILD Study.” European Journal of Allergy and Clinical Immunology. https://doi.org/10.1111/all.13476. Ramani, Sasirekha, et al. 2018. “Human milk oligosaccharides, milk microbiome and infant gut microbiome modulate neonatal rotavirus infection.” Nature Communications. https://doi.org/10.1038/s41467-018-07476-4. Ray, Chandan, et al. 2019. “Human Milk Oligosaccharides: The Journey Ahead.” International Journal of Pediatrics. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6699292/. Song, Xinjie, et al. 2018. “Cronobacter Species in Powdered Infant Formula and Their Detection Methods.” Korean Journal for Food Science of Animal Resources 376-390. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5960834/. Steinmetz, Katy. 2015. “How Millennial Parents Think Differently About Raising Kids.” Time Magazine. https://time.com/4070021/millennial-parents-raising-kids-poll/. Triantis, Vassilis, et al. 2018. “Immunological Effects of Human Milk Oligosaccharides.” Frontiers in Pediatrics. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6036705/. Watson, Elaine. 2017. “Evolve Biosystems: We‘re facing a ‚generational loss‘ of critical gut bacteria in infants.” Food Navigator USA. https://www.foodnavigator-usa.com/Article/2017/05/23/Evolve-BioSystems-warns-of-generatio- nal-loss-of-B.infantis-in-infants#. Wickramasinghe, Saumya, et al. 2015. “Bifidobacteria grown on human milk oligosaccharides downregulate the ex- pression of inflammation-related genes in Caco-2 cells.” BMC Microbiol. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4548914/. Zeuner, Birgitte, et al. 2019. “Synthesis of Human Milk Oligosaccharides: Protein Engineering Strategies for Improved Enzymatic Transglycosylation.” Molecules. https://www.mdpi.com/1420-3049/24/11/2033/pdf. 16
amixon GmbH Halberstaedter Strasse 55 33106 Paderborn Deutschland Telefon: +49-5251-688888-0 Telefax: +49-5251-688888-999 www.amixon.com
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